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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco RTP System

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  Class 2 Device Recall Monaco RTP System see related information
Date Initiated by Firm September 04, 2019
Create Date September 25, 2019
Recall Status1 Open3, Classified
Recall Number Z-2560-2019
Recall Event ID 83692
510(K)Number K183037  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Monaco RTP System, 5.40 Unity, radiation treatment planning system

Product Usage:
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Code Information UDI (01)00858164002190(10) 5.40.00
Recalling Firm/
Manufacturer		 Elekta Inc
13723 Riverport Dr Ste 100
Maryland Heights MO 63043-4819
Manufacturer Reason
for Recall		 It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
FDA Determined
Cause 2		 Software design
Action The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.
Quantity in Commerce 30 units
Distribution Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = Elekta, Inc
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